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BIRMINGHAM HIP RESURFACING (BHR) 74123144Recalls & reported problems

Smith & Nephew, Inc. · FEMORAL HEAD 44MM · Class 3 · Implant

All models of BIRMINGHAM HIP RESURFACING (BHR) (47)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Smith & Nephew Birmingham hip resurfacing femoral head is a metal-on-metal implant that caps the hip's ball rather than replacing the whole joint. Most of the 28 reports describe pain and metal-related tissue reactions from metal debris or elevated metal ion levels, often needing revision surgery years later. There were 27 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
28
Deaths reported
0
Injuries reported
27
Recalls naming it
0

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010552419), received between Oct 26, 2018 and Jan 16, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (17 reports).

29 other recalls cover devices cleared under the same FDA submission (P040033); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Biocompatibility17
  • Adverse Event Without Identified Device or Use Problem8
  • Fracture2
  • Migration2
  • Compatibility Problem1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Loss of Osseointegration1
  • Patient Device Interaction Problem1

Patient problems

  • Metal Related Pathology18
  • Pain8
  • Failure of Implant5
  • Arthralgia2
  • Bone Fracture(s)2
  • High metal ion levels2
  • Infiltration into Tissue2
  • Injury2

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 16, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER AN ORIGINAL BHR SURGERY TOOK PLACE IN 2009, THE FEMORAL HEAD 44MM WAS REVISED ON (B)(6) 2024, BECAUSE OF METAL IONS. A BHR DUAL MOBILITY HEAD AND POLAR STEM WERE IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: High metal ion levels

    MAUDE report 21164942 ↗
  • InjuryMay 27, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2022 DUE TO MECHANICAL COMPLICATION OF INTERNAL PROSTHESIS AND METALLOSIS. DURING THE REVISION, THE METALLIC CUP WAS NOTICED TO BE WELL FIXED, AND IT WAS RETAINED. THE METALLIC FEMORAL HEAD WAS EXPLANTED AND REPLACED. THE NEW SYSTEM IMPLANTED WAS A THA WITH DUAL MOBILITY LINER. PRIMARY RIGHT HIP BHR PROCEDURE WAS PERFORMED ON (B)(6) 2009. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Arthralgia; High metal ion levels; Metal Related Pathology

    MAUDE report 19402110 ↗
  • InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING, DONE ON (B)(6) 2010, THE PATIENT SUFFERED FROM RIGHT RESURFACING TOTAL HIP REPLACEMENT PAIN. THIS CONDITION WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2011. DURING THIS REVISION, THERE APPEARED TO BE EVIDENCE OF IMPINGEMENT ON THE POSTERIOR ASPECT OF THE NECK. THEN THE BHR FEMORAL HEAD WAS REMOVED AND REPLACED WITH A SMITH AND NEPHEW TOTAL HIP REPLACEMENT WHICH INCLUDED AN ANTHOLOGY FEMORAL COMPONENT AND A BHR MODULAR HEAD AND SLEEVE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN SATISFACTORY CONDITIONS, NO COMPLICATIONS.

    Patient problems: Implant Pain; Joint Impingement; Nerve Damage

    MAUDE report 17675161 ↗
  • InjuryApr 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING FOR OSTEOARTHRITIS ¿ A CANADIAN RETROSPECTIVE COHORT STUDY WITH A MINIMUM 10-YEAR FOLLOW-UP", AFTER A BHR RESURFACING SURGERY PERFORMED DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED AN ASEPTIC FEMORAL LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 108 MONTHS AFTER IMPLANTATION. A CONVERSION FROM BHR RESURFACING TO A BHR THA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 16820457 ↗
  • InjuryFeb 20, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO AN ADVERSE REACTION TO METAL DEBRIS. BOTH RESURFACING METALLIC COMPONENTS WERE EXPLANTED AND REPLACED WITH A THA SYSTEM FROM A COMPETITOR. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PRIMARY BHR SURGERY WAS PERFORMED ON (B)(6) 2013.

    Patient problems: Infiltration into Tissue; Metal Related Pathology; Pain

    MAUDE report 16406344 ↗
  • InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BILATERAL BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP AND UNSPECIFIED SYSTEMIC SYMPTOMS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR RESURFACING HEAD WAS EXPLANTED AND REPLACED WITH A THR SYSTEM. INTRAOPERATIVELY, A MILD DARK STAINING OF THE SYNOVIUM WAS NOTED AROUND THE METAL-ON-METAL ARTICULATION. THE PATIENT¿S OUTCOME IS UNKNOWN.

    Patient problems: Arthralgia; Insufficient Information; Metal Related Pathology; Pain

    MAUDE report 15080436 ↗
  • InjuryJun 28, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH METALLOSIS IN HER LEFT HIP. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR RESURFACING HEAD WAS EXPLANTED AND A COMPETITOR¿S DUAL MOBILITY LINER WITH A REPLACED FEMORAL COMPONENT WERE CHOSEN AS NEW COMPONENTS. THE PATIENT¿S OUTCOME IS NOT KNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14848129 ↗
  • InjuryJun 28, 2022Biocompatibility; Biocompatibility

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A BILATERAL BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT AND RIGHT HIP ON (B)(6) 2009 RESPECTIVELY, THE PATIENT REQUIRED A REVISION ARTHROPLASTY OF THE RIGHT HIP IMPLANTS ON (B)(6) 2022. AMONG THE REPORTED SYMPTOMS THAT MADE NECESSARY THIS INTERVENTION, THE PATIENT EXPERIENCED ELEVATED COBALT LEVELS IN BLOOD REFERRED AS TO BE ¿IN THE UPPER 40'S¿. ALTHOUGH THERE IS NO EVIDENCE OF ANY INTERVENTION PERFORMED ON THE LEFT BHR RESURFACING IMPLANTS, THE CONTRIBUTION OF THIS PROSTHESIS TO THE REPORTED COBALT LEVELS COULD NOT BE DISCARDED.

    Patient problems: Metal Related Pathology

    MAUDE report 14844913 ↗
  • InjuryJun 28, 2022Biocompatibility; Biocompatibility

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN, ELEVATED COBALT ION LEVELS IN BLOOD AND PSEUDOTUMOR FORMATION. A MARS MR SCAN SHOWED A LOCAL ADVERSE TISSUE REACTION IN THE RIGHT HIP. A REVISION ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR ACETABULAR CUP AND RESURFACING HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S THR SYSTEM. THE PATIENT¿S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14844271 ↗
  • InjuryMay 26, 2022Biocompatibility; Biocompatibility

    US LEGAL. IT WAS REPORTED THAT, AFTER A PRIMARY RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2009 DUE TO DEGENERATIVE ARTHRITIS WITH MILD DYSPLASIA; THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS INDICATED DUE TO FAILED RIGHT BHR SECONDARY, ADVERSE LOCAL TISSUE REACTION/METALLOSIS AND ELEVATED SERUM COBALT/CHROMIUM ION LEVELS. THE STATUS OF THE PLAINTIFF IS UNKNOWN.

    Patient problems: Metal Related Pathology; Swelling/ Edema

    MAUDE report 14504043 ↗
  • InjuryMay 20, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON (B)(6) 2012 DUE TO SEVERE OSTEOARTHRITIS, THE PATIENT EXPERIENCED ELEVATED LEVELS OF COBALT AND CHROMIUM IN BLOOD. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020, IN WHICH THE BHR FEM HEAD WAS EXPLANTED AND THE BHR ACETABULAR CUP WAS RETAINED. THE NEXT DAY, THE PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC FRACTURE, FOR WHICH A SECOND REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE IMPLANTS PLACED IN THE FIRST AND SECOND REVISION SURGERY ARE FROM ANOTHER MANUFACTURER. THE BHR ACETABULAR CUP HAS NOT BEEN EXPLANTED. THE PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14462814 ↗
  • InjuryMay 18, 2022Migration; Migration

    IT WAS REPORTED THAT ON LITERATURE REVIEW "HIP RESURFACING: A SINGLE SURGEON U.S. SERIES WITH MINIMUM TEN-YEAR FOLLOW-UP¿ 2.2 YEARS AFTER A BHR SURGERY, ONE (1) PATIENT DEVELOPED SUBSIDENCE OF THE FEMORAL COMPONENT DUE TO FEMORAL HEAD COLLAPSE AND PAIN. REVISION SURGERY WAS PERFORMED TO EXPLANT BOTH IMPLANTS. THE PATIENT OUTCOME AND CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Discomfort

    MAUDE report 14431325 ↗
  • InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    US LEGAL - IT WAS REPORTED THAT, AFTER LEFT HIP BHR PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED A FAILED RESURFACING PROCEDURE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION, MINIMAL SYNOVIAL FLUID WAS FOUND WITH NO EVIDENCE OF METAL DEBRIS. THE FEMORAL HEAD WAS EXPLANTED, AND THE CUP WAS RETAINED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION.

    Patient problems: Failure of Implant

    MAUDE report 14430730 ↗
  • InjuryApr 13, 2022Biocompatibility; Biocompatibility

    US LEGAL: IT WAS REPORTED THAT, AFTER LEFT BIRMINGHAM HIP RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN, STIFFNESS, CATCHING AND DECREASED ACTIVITY CAPABILITIES, THE PATIENT EXPERIENCED PAIN, SIGNIFICANT FLUID COLLECTION AROUND HER POSTERIOR HIP CAPSULES, AS WELL AS SIGNIFICANTLY ELEVATED CHROMIUM AND COBALT IONS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020, IN WHICH A DUSKY GRAY-APPEARING INFLAMED SYNOVIUM WAS NOTICED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology; Pain; Synovitis

    MAUDE report 14101993 ↗
  • InjuryMar 28, 2022Fracture; Fracture

    US LEGAL. IT WAS REPORTED THAT AFTER A RIGHT BHR ON (B)(6) 2013, PLAINTIFF HAD A FEMORAL HEAD FRACTURE. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE HEAD WAS EXPLANTED. PLAINTIFF OUTCOME IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 13927117 ↗
  • InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    US LEGAL BILATERAL PATIENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2012 DUE TO PERIPROSTHETIC FEMORAL NECK FRACTURE (CONVERSION FROM BHR TO BHR THA). THE PRIMARY LEFT BHR WAS PERFORMED ON (B)(6) 2009. THE PATIENT STATUS IS UNKNOWN.

    Patient problems: Bone Fracture(s); Hip Fracture

    MAUDE report 13896917 ↗
  • InjuryJan 12, 2022Biocompatibility; Biocompatibility

    US LEGAL: IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A MEDICALLY INDICATED REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2020 DUE TO PAIN IN THE JOINT AND METALLOSIS. THE OUTCOME OF THE PATIENT IS UNKNOWN. THE LEFT HIP BHR PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009.

    Patient problems: Metal Related Pathology

    MAUDE report 13242327 ↗
  • InjuryDec 27, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED ELEVATED CHROMIUM AND COBALT LEVELS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 13087697 ↗
  • InjuryDec 24, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER RIGHT BHR IN (B)(6) 2010, THE PLAINTIFF HAS SUFFERED OF SEVERE PAIN, METALLOSIS, ADVERSE LOCAL TISSUE REACTION, BROWN SYNOVIUM CONSISTENT WITH PSEUDOTUMOR AND LOOSENING OF THE FEMORAL COMPONENT. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2019. THE FEMORAL HEAD WAS EXPLANTED AND, AS THE CUP WAS WELL FIXED IN PLACE, IT WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS BROUGHT TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION.

    Patient problems: Metal Related Pathology

    MAUDE report 13084423 ↗
  • InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    **US LEGAL MDL** IT WAS REPORTED THAT AFTER A LEFT BHR CONSTRUCT WAS IMPLANTED ON (B)(6)2012 PLAINTIFF EXPERIENCED LEG DISCREPANCY OVER 2CM, PROGRESSIVE PAIN, AND DIFFICULT AMBULATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY A LARGE HEMARTHROSIS WAS FOUND AND EVACUATED. ALSO, PSEUDOTUMOR TISSUE FOUND AN EXTENSIVE SYNOVITIS AROUND THE FEMORAL NECK. THE LINER AND BHR HEAD WERE EXPLANTED AND REPLACE, BUT THE ACETABULAR CUP REMAINED. ADDITIONALLY, A STEM (NOT FROM S+N) WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Unequal Limb Length

    MAUDE report 12639264 ↗
  • InjuryJul 8, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S RIGHT HIP ON (B)(6) 2013, THE PLAINTIFF EXPERIENCED ELEVATED COBALT AND CHROMIUM LEVELS (22.8 PPB) AND A LARGE PSEUDOTUMOR FORMATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE FEMORAL HEAD WAS EXPLANTED, AND THE CUP WAS LEFT IN PLACE. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology; Solid Tumor

    MAUDE report 12135298 ↗
  • InjuryJun 24, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR PRIMARY SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HIP PAIN AND RAISED METAL LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE FEMORAL HEAD 44MM (CASE (B)(4)) AND ACETABULAR CUP HAP SIZE 44/52 (CASE (B)(4)) WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Failure of Implant; Infiltration into Tissue; Metal Related Pathology; Pain

    MAUDE report 12059515 ↗
  • InjuryMay 31, 2021Fracture; Fracture

    IT WAS REPORTED THAT AFTER A RIGHT BHR ON (B)(6) 2013, PLAINTIFF HAD A FEMORAL NECK FRACTURE. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE HEAD WAS EXPLANTED. PLAINTIFF OUTCOME IS UNKNOWN.

    Patient problems: Bone Fracture(s); Failure of Implant

    MAUDE report 11910711 ↗
  • MalfunctionMay 26, 2021Biocompatibility; Biocompatibility

    *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED PAIN, LIMITED MOBILITY, EXTENSIVE METALLOSIS AND ADVERSE LOCAL TISSUE REACTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. DURING SURGERY, THE CUP WAS FOUND TO BE IN GOOD POSITION AND WELL FIXED, SO THE SURGEON DECIDED NOT TO EXPLANT IT. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

    MAUDE report 11891193 ↗
  • InjuryMar 12, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, A REVISION SURGERY WHERE A DEVICE WAS EXPLANTED HAPPENED ON (B)(6) 2021 DUE TO METALLOSIS.

    Patient problems: Failure of Implant; Metal Related Pathology

    MAUDE report 11476431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040033. One submission often covers many models, so check the product and lot details in each record.

  • Z-2242-2021 · Jul 14, 2021 · Terminated
    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
  • Z-2268-2018 · May 11, 2018 · Terminated
    Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Siz
  • Z-2267-2018 · May 11, 2018 · Terminated
    Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
  • Z-2745-2015 · Jun 3, 2015 · Terminated
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 M
  • Z-2747-2015 · Jun 3, 2015 · Terminated
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Pro
  • Z-2746-2015 · Jun 3, 2015 · Terminated
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74
  • Z-0022-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
  • Z-0023-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.
  • Z-0024-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
  • Z-0028-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
  • Z-0027-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.
  • Z-0016-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
  • Z-0020-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
  • Z-0030-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
  • Z-0021-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.

…and 14 more.

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